Sanofi: Global Regulatory Affairs Strategy General Medicines Unit
Overview:
Sanofi’s ambition is to leverage science and innovation to improve people’s lives, becoming the first biopharma company powered by artificial intelligence at scale and the industry leader in immunology and oncology. The Global Regulatory Affairs (GRA) team at Sanofi works to provide regulatory expertise using innovative and prompt guidance for product development and life cycle management of marketed products.
Goal:
The GRA Fellowship is focused on providing the fellow with the necessary skills and tools to become a knowledgeable, confident, and strategic regulatory affairs professional. The fellow will have a well-rounded understanding of the regulatory functions and drug development process from the early stage to post-marketing, including how technology, especially artificial intelligence, can be leveraged to enhance our ways or working.
Objectives:
- Develop regulatory strategic skills while contributing to global pre- and post-approval planning and submissions potentially including briefing documents, Health Authority interactions, IND/CTA submissions, BLA/NDA/MAA applications.
- Lead team meetings, develop regulatory strategy, and contribute to and lead Health Authority submissions with increasing responsibility throughout the Fellowship program.
- Partner with contributing functions within Sanofi to build and implement regulatory strategies globally.
- Experience various facets of GRA to better understand the roles of regulatory professionals.
- Engage with global colleagues and learn country/region- specific global regulatory processes.
- Develop skills such as strategic and analytical thinking, effective communication, business acumen and partnering/collaboration.
Sanofi Component:
The fellow will be following a development plan with given exposure and project-driven experiences to develop the tactical and strategic capabilities needed to be a successful regulatory professional. Ultimately becomes an integrated part of the GRA team through involvement in cross-functional projects with global colleagues.
Ideal Candidate:
- PharmD
- Desire to learn the skills needed for developing a regulatory strategy for products in both the pre-approval and post- approval setting
- Be motivated to collaborate with multidisciplinary teams to meet business objectives
- Be open to learning and interpreting regulations and applying them to develop a regulatory strategy and implement it within a larger regulatory strategic plan
- Candidates with a passion for science, independent work ethic, collaborative spirit, solutions- oriented mindset, and strong time management skills are encouraged to apply